Safety Physician

🔥 11 minutes ago

🌐 Poland, United Kingdom, +4 more countries – Remote

🇵🇱 Poland – Remote 🇬🇧 United Kingdom – Remote 🇭🇺 Hungary – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote

💵 zł340.1k - zł511.2k / year

⏰ Full Time

🟠 Senior

🔴 Lead

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Manage all aspects of Drug Safety and Pharmacovigilance, including safety data review, signal detection, risk communication, safety information updates, and risk mitigation • Provide medical and drug safety expertise for risk-benefit assessment, clinical trial data interpretation, and medical review of individual SAE case reports • Collaborate with CRO Safety Physicians/Team, Medical Directors, Clinical Scientists, and other functions on safety monitoring, assessment, and reporting • Contribute to safety sections of study protocols, study reports, IBs, ICFs, and responses to regulatory agencies, IRBs, and Ethics Committees • Set up and run DSMBs or safety data review meetings • Participate in routine safety cohort reviews for ongoing Phase 1 dose-escalation studies • Perform event coding review and clinical and safety database reconciliation • Oversee Drug Safety systems and safety database ownership and access • Ensure effective SOPs and safety vendor governance • Plan future Drug Safety and Pharmacovigilance development for regulatory filings and commercialization, including QPPV support, Risk Management Plans, and a Pharmacovigilance System Master File • Maintain audit and inspection readiness • Monitor regulatory compliance of safety reporting throughout trials • Lead and contribute to Drug Safety process development and improvements

🎯 Requirements

• MD required • Minimum of 7 years in Drug Safety related activities in pharma/biotech • Clinical trial experience, including oncology drug safety, with at least 3 years in early clinical development • Experience authoring, reviewing, and providing input to drug-safety related regulatory reports • Successful involvement in regulatory agency interactions or inspections • Strong knowledge of FDA, EU, ICH and other global regulatory requirements for safety reporting and safety data and risk management • Solid medical knowledge and familiarity with medical concepts and terminology used in hematology/oncology clinical trials and safety monitoring • Proficiency with standard computer applications, including Microsoft Office and Windows, and safety databases • Experience with case processing in ARGUS • Experience of Analysis of Similar Events (AoSE) and patient safety narratives • Less than 20% travel • Ability to challenge existing practices and adapt to a variety of situations • Ability to meet quality and performance standards • Strong influencing skills • Excellent written and oral communication skills • Ability to work effectively as a team member and promote collaboration • Demonstrated ownership, initiative, and accountability

🏖️ Benefits

• Discretionary annual bonus • Private medical insurance • MultiSport Card • Life insurance • Pension • Home working allowance • Vacation • Other benefits